For Industry

REMS Integration Initiative

In 2011, FDA launched the REMS Integration Initiative with the goal of evaluating and improving our implementation of Risk Evaluation and Mitigation Strategies (REMS) authorities. The REMS Integration Initiative was built on stakeholder feedback including at least 3 public meetings, 5 workshops, 15 listening sessions, and a pilot with 9 REMS application holders. FDA also engaged outside entities, including think-tanks and standards development organizations to ensure comprehensive stakeholder representation. (A discussion of some of the issues identified and addressed during this initiative can be found here.)

Most of the activities completed under the REMS integration initiative were chosen to address specific stakeholder concerns. FDA published 5 guidances (listed below) to address topics including the determination of when a REMS is necessary, format of REMS documents, and tools for electronic submission. FDA also published 3 reports (also listed below) describing targeted projects to address specific stakeholder concerns, including building the REMS@FDA website. A webinar describing work completed under this initiative can be found here.

The REMS Integration Initiative ended in October 2017, but efforts to evaluate and advance the REMS program endure. The REMS Platform Standards Initiative is just one example of an ongoing project to continue improving REMS; a key part of FDA’s mission to make safe and effective therapies available, and to always protect and promote the public health.